On January 15th, 2025 the US Food and Drug Administration amended its regulations around color additives to no longer allow the use of FD&C Red No. 3 in ingested drugs or foods, and is enforcing a January 28th, 2028 deadline for companies to remove the additive from affected products.
The decision is based on the Delaney Clause of the Federal Food, Drug, and Cosmetics Act which prohibits the use of food or color additives found to cause cancer in humans or animals. A recent study concluded that FD&C Red No. 3 causes cancer in laboratory studies with male rats.
